Bristol Myers Squibb
AssociateDirector,ClinicalDataManagement
“Associate Director, Clinical Data Management at Bristol Myers Squibb. Skills: Clinical Data Management, Program Management, Line Management, Vendor Oversight. Provide oversight of a program. Establish a governance framework”
What You'll Achieve.
Ensure studies within the program are delivered per corporate goals and objectives; Ensure monitoring of risks and mitigation strategies; Ensure appropriate support is in place to provide data quality oversight; Deliver complete, high quality and reliable clinical trial data in a timely manner; Ensure on-going review of trial data currency, quality and completeness; Ensure timely closure of CAPA action items
Industry & Context.
Resolve complex issues; Proactively develop solutions; Leveraging technical/functional expertise to develop solutions; Using clear communications and collaborative strategies to drive to resolution
What They're Looking For.
Must Have
Bachelor's Degree, 7 years of relevant industry experience, Knowledge of Clinical Drug Development Process, Knowledge of regulatory and ICH guidelines, Knowledge of industry standard practices regarding data management, Knowledge and experience of EDC systems, Demonstrated knowledge of Microsoft Office skills, Well versed in industry trends and emerging technologies supporting data collection, Expertise in metrics analysis and reporting methodologies, Solid knowledge of submission requirements
Nice to Have
Advanced degree, Project management certification (e.g. PMP), Experience in managing late phase studies and portfolio for Data Management, Medidata RAVE preferred
What You'll Do.
Provide oversight of a program
Establish a governance framework
Develop productive working relationships
Attend program level strategic meetings
Set program level data collection standards
Line management responsibility
Manage resource assignments
Forecast future resource needs
Assign resources to initiatives
Coach and mentor staff
Promote a workplace culture
and deliver clinical trial data
Provide clinical data management leadership
Responsible for end-to-end clinical data management activities
Provide quality and project oversight
Gather content and integration requirements
Enforce data standard conventions
review/revise DM related study plans
Participate in Data Quality Review meetings
Represent DM on cross-functional project teams
Lead or support Health Authority inspections
Provide FSP/CRO/Vendor oversight
Support change management initiatives
Evaluate and recommend new technologies
Mentor new or existing team members
Lead CAPA management activities
Resolve complex issues
Author procedural documents
How You'll Work.
Team & Collaboration
Develop productive working relationships with cross functional stakeholders; Represent DM on cross-functional project teams; Collaborate with partners supporting other data collection systems; Participate in Data Quality Review meetings with cross functional study team members; Work collaboratively on multi-disciplinary project teams
Communication Scope
Excellent oral and written communication skills; Communicate effectively with senior management and cross-functional teams
Process & Methodology
Program Management, Project Management, Oversight of a program, Governance framework, Risk mitigation strategies, Resource assignments, Resource needs forecasting, Initiative assignment, End-to-end clinical data management activities, Quality and project oversight, CAPA management
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